End Stage Renal DiseaseNCT04747067
To Assess the Effect of HDF Versus High Flux Dialysis on Free Light Chains and Cumulative Albumin Loss, in End Stage Renal Disease Patients.
A study testing BIOPURE 260HF dialyzer in people with End Stage Renal Disease and Hemodiafiltration, run by Ain Shams University at 1 site in Egypt.
Trial summary
Removal of uremic toxins is the main goal of HD, It was improved by using high volume convective technique with high flux (HF) dialyzer. This technique removes medium - large molecular weight solutes giving higher dialysis adequacy and consequently improving the quality of life. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- End Stage Renal Disease, Hemodiafiltration, Hemodialysis
- What is being tested?
- BIOPURE 260HF dialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Prevalent HD patients on regular hemodialysis sessions for >6 months 3 sessions/week of 4 hours duration.
- Patients with Arterio-venous fistula as dialysis access.
Who cannot join
- Patients with hemodialysis catheters.
- Patients with active inflammation or infection.
- Decompensated heart failure.
- Liver Cell Failure ( Child B,C)
- Patients with known malignancies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hemodiafiltration Versus High Flux Dialysis On Free Light Chains Reduction And Its Relation To Albumin Loss.
Removal of uremic toxins is the main goal of HD, It was improved by using high volume convective technique with high flux (HF) dialyzer. This technique removes medium - large molecular weight solutes giving higher dialysis adequacy and consequently improving the quality of life.
This study will assess the effect of hemodiafiltration (HDF) versus high flux dialysis on free light chains (FLC) reduction as a marker of HD adequacy and its relation to albumin loss using dialyzer effective surface area 2.6m2.
- Conditions
- End Stage Renal Disease, Hemodiafiltration, Hemodialysis
- Being tested
- BIOPURE 260HF dialyzer
- Keywords
- End stage renal disease (ESRD), hemodiafiltration (HDF), hemodialysis (HD), Free light chains, Albumin loss, Kappa and lambda
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOPURE 260HF dialyzerDevice
Dialyzer with effective surface area 2.6 m2, High-flux polyethersulfone hollow fiber with steam sterilization, myoglobin sieving coefficient (SC) 0.7, membrane cutoff 40,000 Daltons (Allmed Medical Gmbh)
| Study group | Role | What they receive |
|---|---|---|
| High-flux Hemodialysis | Experimental | patients treated by conventional hemodialysis Receives: Device: BIOPURE 260HF dialyzer |
| Hemodiafiltration | Experimental | patients treated by online post-dilution hemodialysis Receives: Device: BIOPURE 260HF dialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free light chain reduction
Measurement of kappa (23KDa) and lambda (45 KDa)free light chains levels, pre and post dialysis session, in patients undergoing high-flux dialysis versus HDF.
Measured: 1 day of hemodialysis session
Secondary outcomes (1)
Cumulative albumin loss
Assessment of cumulative dialysate albumin loss by measuring albumin spent in dialysate -hourly- in patients undergoing high flux dialysis versus HDF
Measured: 1 day of hemodialysis session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Feb 2021
- Primary completion1 May 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- It is a pilot crossover study, 25 ESRD patients were dialyzed using dialyzer; BIOPURE 260 HF on a single session on two hemodialysis modalities (conventional HD and online post-dilution HDF) with washout period of 2 weeks using high flux dialyzers with maximum surface area 2.0 m2.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Sultan, Ain Shams University
- Investigators
- Reem Sultan, M.Sc, Principal investigator, Faculty of Medicine, Ain Shams Univeristy.Hesham ElSayed, PhD, Study chair, Faculty of Medicine, Ain Shams UniveristyMagdy ElSharkawy, PhD, Study chair, Faculty of Medicine, Ain Shams UniveristyWaleed AbdelMohsen, PhD, Study director, Faculty of Medicine, Ain Shams UniveristyShaimaa Zaki, PhD, Study director, Faculty of Medicine, Ain Shams UniveristyAhmed Emara, PhD, Study director, Faculty of Medicine, Ain Shams Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747067
- Sponsor's protocol ID
- HD vs HDF
- Status last verified
- Mar 2022
- First submitted
- 6 Feb 2021
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bourguignon C, Chenine L, Bargnoux AS, Leray-Moragues H, Canaud B, Cristol JP, Morena M. Hemodiafiltration improves free light chain removal and normalizes kappa/lambda ratio in hemodialysis patients. J Nephrol. 2016 Apr;29(2):251-257. doi: 10.1007/s40620-015-0207-z. Epub 2015 May 29.
PubMed 26022721Donati G, Moretti MI, Baraldi O, Spazzoli A, Capelli I, Comai G, Marchetti A, Sarma M, Mancini R, La Manna G. Removal of free light chains in hemodialysis patients without multiple myeloma: a crossover comparison of three different dialyzers. BMC Nephrol. 2016 Nov 25;17(1):193. doi: 10.1186/s12882-016-0405-5.
PubMed 27884120Lamy T, Henri P, Lobbedez T, Comby E, Ryckelynck JP, Ficheux M. Comparison between on-line high-efficiency hemodiafiltration and conventional high-flux hemodialysis for polyclonal free light chain removal. Blood Purif. 2014;37(2):93-8. doi: 10.1159/000357968. Epub 2014 Mar 1.
PubMed 24603634Maduell F. Hemodiafiltration versus conventional hemodialysis: Should "conventional" be redefined? Semin Dial. 2018 Nov;31(6):625-632. doi: 10.1111/sdi.12715. Epub 2018 May 29.
PubMed 29813181Nagai K, Tsuchida K, Ishihara N, Minagawa N, Ichien G, Yamada S, Hirose D, Michiwaki H, Kanayama HO, Doi T, Minakuchi J. Implications of Albumin Leakage for Survival in Maintenance Hemodialysis Patients: A 7-year Observational Study. Ther Apher Dial. 2017 Aug;21(4):378-386. doi: 10.1111/1744-9987.12526. Epub 2017 Apr 27.
PubMed 28452109van Gelder MK, Abrahams AC, Joles JA, Kaysen GA, Gerritsen KGF. Albumin handling in different hemodialysis modalities. Nephrol Dial Transplant. 2018 Jun 1;33(6):906-913. doi: 10.1093/ndt/gfx191.
PubMed 29106652Wolley M, Jardine M, Hutchison CA. Exploring the Clinical Relevance of Providing Increased Removal of Large Middle Molecules. Clin J Am Soc Nephrol. 2018 May 7;13(5):805-814. doi: 10.2215/CJN.10110917. Epub 2018 Mar 5.
PubMed 29507008Wolley MJ, Hutchison CA. Large uremic toxins: an unsolved problem in end-stage kidney disease. Nephrol Dial Transplant. 2018 Oct 1;33(suppl_3):iii6-iii11. doi: 10.1093/ndt/gfy179.
PubMed 30281131
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hemodiafiltration Versus High Flux Dialysis On Free Light Chains Reduction And Its Relation To Albumin Loss.
- ClinicalTrials.gov ID
- NCT04747067
- Acronym / sponsor ID
- HD vs HDF
- Conditions
- End Stage Renal Disease, Hemodiafiltration, Hemodialysis
- Keywords
- End stage renal disease (ESRD), hemodiafiltration (HDF), hemodialysis (HD), Free light chains, Albumin loss, Kappa and lambda
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Removal of uremic toxins is the main goal of HD, It was improved by using high volume convective technique with high flux (HF) dialyzer. This technique removes medium - large molecular weight solutes giving higher dialysis adequacy and consequently improving the quality of life.
This study will assess the effect of hemodiafiltration (HDF) versus high flux dialysis on free light chains (FLC) reduction as a marker of HD adequacy and its relation to albumin loss using dialyzer effective surface area 2.6m2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It is a pilot crossover study, 25 ESRD patients were dialyzed using dialyzer; BIOPURE 260 HF on a single session on two hemodialysis modalities (conventional HD and online post-dilution HDF) with washout period of 2 weeks using high flux dialyzers with maximum surface area 2.0 m2.
| Arm | Type | Receives |
|---|---|---|
| High-flux Hemodialysis | Experimental | Device: BIOPURE 260HF dialyzerpatients treated by conventional hemodialysis |
| Hemodiafiltration | Experimental | Device: BIOPURE 260HF dialyzerpatients treated by online post-dilution hemodialysis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Prevalent HD patients on regular hemodialysis sessions for >6 months 3 sessions/week of 4 hours duration.
- Patients with Arterio-venous fistula as dialysis access.
Key exclusion criteria (5 listed)
- Patients with hemodialysis catheters.
- Patients with active inflammation or infection.
- Decompensated heart failure.
- Liver Cell Failure ( Child B,C)
- Patients with known malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIOPURE 260HF dialyzerDialyzer with effective surface area 2.6 m2, High-flux polyethersulfone hollow fiber with steam sterilization, myoglobin sieving coefficient (SC) 0.7, membrane cutoff 40,000 Daltons (Allmed Medical Gmbh) | Device | Hemodiafiltration, High-flux Hemodialysis |
Primary outcome
Free light chain reduction
Time frame: 1 day of hemodialysis session
Measurement of kappa (23KDa) and lambda (45 KDa)free light chains levels, pre and post dialysis session, in patients undergoing high-flux dialysis versus HDF.
1 secondary outcome
Cumulative albumin loss
Time frame: 1 day of hemodialysis session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Background: PubMed 26022721Bourguignon C, Chenine L, Bargnoux AS, Leray-Moragues H, Canaud B, Cristol JP, Morena M. Hemodiafiltration improves free light chain removal and normalizes kappa/lambda ratio in hemodialysis patients. J Nephrol. 2016 Apr;29(2):251-257. doi: 10.1007/s40620-015-0207-z. Epub 2015 May 29.
- Background: PubMed 27884120Donati G, Moretti MI, Baraldi O, Spazzoli A, Capelli I, Comai G, Marchetti A, Sarma M, Mancini R, La Manna G. Removal of free light chains in hemodialysis patients without multiple myeloma: a crossover comparison of three different dialyzers. BMC Nephrol. 2016 Nov 25;17(1):193. doi: 10.1186/s12882-016-0405-5.
- Background: PubMed 24603634Lamy T, Henri P, Lobbedez T, Comby E, Ryckelynck JP, Ficheux M. Comparison between on-line high-efficiency hemodiafiltration and conventional high-flux hemodialysis for polyclonal free light chain removal. Blood Purif. 2014;37(2):93-8. doi: 10.1159/000357968. Epub 2014 Mar 1.
- Background: PubMed 29813181Maduell F. Hemodiafiltration versus conventional hemodialysis: Should "conventional" be redefined? Semin Dial. 2018 Nov;31(6):625-632. doi: 10.1111/sdi.12715. Epub 2018 May 29.
- Background: PubMed 28452109Nagai K, Tsuchida K, Ishihara N, Minagawa N, Ichien G, Yamada S, Hirose D, Michiwaki H, Kanayama HO, Doi T, Minakuchi J. Implications of Albumin Leakage for Survival in Maintenance Hemodialysis Patients: A 7-year Observational Study. Ther Apher Dial. 2017 Aug;21(4):378-386. doi: 10.1111/1744-9987.12526. Epub 2017 Apr 27.
- Background: PubMed 29106652van Gelder MK, Abrahams AC, Joles JA, Kaysen GA, Gerritsen KGF. Albumin handling in different hemodialysis modalities. Nephrol Dial Transplant. 2018 Jun 1;33(6):906-913. doi: 10.1093/ndt/gfx191.
- Background: PubMed 29507008Wolley M, Jardine M, Hutchison CA. Exploring the Clinical Relevance of Providing Increased Removal of Large Middle Molecules. Clin J Am Soc Nephrol. 2018 May 7;13(5):805-814. doi: 10.2215/CJN.10110917. Epub 2018 Mar 5.
- Background: PubMed 30281131Wolley MJ, Hutchison CA. Large uremic toxins: an unsolved problem in end-stage kidney disease. Nephrol Dial Transplant. 2018 Oct 1;33(suppl_3):iii6-iii11. doi: 10.1093/ndt/gfy179.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reem Sultan, M.Sc principal investigator
Faculty of Medicine, Ain Shams Univeristy.
Hesham ElSayed, PhD study chair
Faculty of Medicine, Ain Shams Univeristy
Magdy ElSharkawy, PhD study chair
Faculty of Medicine, Ain Shams Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIOPURE 260HF dialyzer in people with End Stage Renal Disease and Hemodiafiltration, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free light chain reduction (time frame: 1 day of hemodialysis session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04747067, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.